As many as 6 million people in the U.S. suffer from gout, a type of arthritis in which deposits of uric acid build up around joints, causing pain, swelling and stiffness.

Acute gout is a painful condition that typically affects one joint.Chronic gout is repeated episodes of pain and inflammation, which may involve more than one joint.

KRYSTEXXA FROM SAVIENT PHARMA IS HELPFUL FOR SEVERE GOUT SUFFERERSSavient Pharmaceuticals Inc.’s treatment for chronic, severe gout helped patients who didn’t respond to other medications, about 3 percent of of the market. These were targeted for the trials, conducted in 2006 and 2007.

Savient’s Krystexxa, approved by the U.S. regulators in 2010, lowered uric acid levels below targeted amounts in 42 percent of 84 patients given the drug biweekly, compared with 35 percent who took the medicine monthly, and zero response in the placebo group, according to the research published in the Journal of the American Medical Association.

NOVARTIS HAS PROMISING DRUG FOR GOUTIn June 2011 the U.S. FDA regulatory panel questioned the safety of the gout treatment Ilaris (canakinumab or ACZ885), asking for more testing.

The adverse regulatory stance could delay or block the launch of Ilaris in the U.S. if the FDA backs the panel.

One of Novartis's top blockbuster hopefuls registered promising data in two pivotal trials for gout, offering supportive data for a string of regulatory filings in Europe and the U.S.

ACZ885--an antibody also known as Ilaris which blocks the interleukin-1 beta protein--provided significantly improved pain relief and a sharp reduction in the risk of fresh attacks of gout compared to an injectable steroid. Investigators recruited more than 450 patients for the studies who didn't fit the profile for standard therapies.

Analysts give the treatment a solid shot at achieving blockbuster status with more than a billion dollars in annual revenue--provided the pharma company can continue to broaden the use of the drug beyond the one percent to four percent of the population which suffers from gouty arthritis with new indications for use.

Professor Alexander So, one of the studies' investigators says:"Scientists only recently learned that the root cause of the pain in gouty arthritis is interleukin-1 beta. Through specifically targeting interleukin-1 beta, these studies show ACZ885 can effectively treat painful attacks while extending the time to new attacks."

REGENERON PHARMA HAS PROMISING THERAPY IN PHASE 3Regeneron Pharmaceuticals Inc. (REGN) said its gout therapy Arcalyst met all its primary and secondary goals in Phase 3 studies, a milestone on its path to regulatory approval.

Those taking an injection of 80 or 160 milligrams a week of Arcalyst over four months had a decrease of 72 percent in gout flares compared with placebo.

The data, from the third and final stage of testing generally required for approval, will support an application with U.S. regulators by mid-2011, the company said.

About 750,000 gout patients start taking uric acid-lowering therapy such as allopurinol each year.During the first few months of therapy, the breakup of uric acid crystals can cause flares of joint pain, which Arcalyst aims to prevent. If successful, the medicine may generate up to $500 million in annual revenue.

Arcalyst “may have significant potential as a co-treatment in allopurinol initiation for chronic gout.

RDEA594 TESTED FOR NORMALIZING URIC ACID IN GOUTThe lead product from Ardea Biosciences, Inc., of San Diego, California, is Lesinurad (RDEA594), for the chronic management of hyperuricemia in patients with gout. It is a once-daily, oral inhibitor of the URAT1 transporter.

The company has completed Phase 2b clinical studies of lesinurad and continue preparations for Phase 3 development.